12.07.2014 Views

ULTRA FAST-FIX™ Meniscal Repair System - Smith & Nephew

ULTRA FAST-FIX™ Meniscal Repair System - Smith & Nephew

ULTRA FAST-FIX™ Meniscal Repair System - Smith & Nephew

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

Knee Series<br />

Technique Guide<br />

<strong>ULTRA</strong> <strong>FAST</strong>-FIX<br />

<strong>Meniscal</strong> <strong>Repair</strong> <strong>System</strong><br />

All-Inside <strong>Meniscal</strong> <strong>Repair</strong><br />

with the <strong>ULTRA</strong> <strong>FAST</strong>-FIX<br />

<strong>Meniscal</strong> <strong>Repair</strong> <strong>System</strong><br />

Nick Sgaglione, MD<br />

David Caborn, MD


Reviewed by:<br />

Nick Sgaglione, MD<br />

Associate Professor of Orthopedic Surgery<br />

Albert Einstein College of Medicine<br />

Great Neck, NY<br />

David Caborn, MD<br />

Director of Sports Medicine<br />

University of Louisville<br />

Louisville, KY<br />

2


All-Inside <strong>Meniscal</strong> <strong>Repair</strong><br />

with the <strong>ULTRA</strong> <strong>FAST</strong>-FIX<br />

<strong>Meniscal</strong> <strong>Repair</strong> <strong>System</strong><br />

Introduction<br />

<strong>Repair</strong> of peripheral and red/white meniscal tears<br />

has become the standard of care as evidence<br />

accumulates supporting meniscal preservation and<br />

its role in joint nutrition, lubrication, stability, load<br />

transmission, shock absorption, neuromuscular<br />

proprioception, and prevention of intra-articular<br />

chondrosis and arthrosis.<br />

Inside-Out and Outside-In procedures require<br />

additional incisions and dissection to avoid<br />

neurovascular complications and have the potential<br />

to cause capsular tethering, neuroma formation,<br />

and suboptimal repair tension secondary to knot<br />

tying over excess tissue. In addition, prolonged<br />

intraoperative and tourniquet time can cause<br />

increased pain and morbidity as well as increased<br />

anesthesia costs.<br />

The All-Inside arthroscopic approach has gained<br />

popularity because of its insertion ease and<br />

potential minimization of the aforementioned<br />

problems. However, many of the devices used<br />

in this approach have demonstrated inferior<br />

biomechanical properties and have been associated<br />

with breakage, loosening, distraction of the repair,<br />

neurological injury, subcutaneous prominence, and<br />

articular cartilage abrasion and damage. These<br />

complications have contributed to a recent trend<br />

back to the Inside-Out and Outside-In techniques,<br />

despite their inherent difficulties.<br />

3


Overview<br />

The <strong>ULTRA</strong> <strong>FAST</strong>-FIX <strong>Meniscal</strong> <strong>Repair</strong> <strong>System</strong> (Photo 1) provides a strong, reproducible, reliable, and time-efficient meniscal<br />

repair with equal biomechanical properties to the open vertical mattress suture technique 1 . This result is achieved without the<br />

associated comorbidities of Inside-Out or Outside-In meniscal repair and without the need for intra-articular knot tying.<br />

The <strong>ULTRA</strong> <strong>FAST</strong>-FIX <strong>Meniscal</strong> <strong>Repair</strong> <strong>System</strong> also gives the surgeon the versatility of placing horizontal or vertical mattress<br />

suture fixation, without risk to neurovascular structures. As with all arthroscopic procedures, good visualization of the<br />

meniscal tear and adequate arthroscopic distention are essential. To minimize the potential for damage to neurovascular<br />

structures, <strong>Smith</strong> & <strong>Nephew</strong> recommends the use of the curved delivery needle and the variable depth penetration limiter (as<br />

indicated by the meniscal tear position, especially if a vertical mattress suture is utilized).<br />

Diamond rasp, 45°<br />

Diamond rasp, 90°<br />

Curved knot pusher/suture cutter<br />

Straight knot pusher/suture cutter<br />

<strong>ULTRA</strong> <strong>FAST</strong>-FIX, Reverse Curved<br />

<strong>ULTRA</strong> <strong>FAST</strong>-FIX, Curved<br />

Blue split cannula<br />

<strong>ULTRA</strong> <strong>FAST</strong>-FIX AB, Curved<br />

Suture funnel<br />

Metal slotted cannula<br />

Adjustable depth penetration limiter<br />

Depth probe<br />

Photo 1. <strong>ULTRA</strong> <strong>FAST</strong>-FIX <strong>Meniscal</strong> <strong>Repair</strong> <strong>System</strong><br />

4


Setup<br />

Each <strong>ULTRA</strong> <strong>FAST</strong>-FIX device contains two 5 mm<br />

polymer integrated anchors (resorbable or bio-inert),<br />

with a pre-tied, self-sliding knot comprised of #0,<br />

non-absorbable, UHMW polyethelene <strong>ULTRA</strong>BRAID<br />

co-braid suture. The entire system is packaged in<br />

an easy-to-insert, integrated delivery needle. The<br />

anchors are placed into the meniscus sequentially,<br />

seated safely beyond the capsule, and are then<br />

tightened in a simple manner without the need for<br />

arthroscopic knot tying (Photos 2 and 3).<br />

The dark blue sheath comes preset to a depth of 25<br />

mm from the tip of the needle and 17 mm from the<br />

back of the implant, which has been shown to avoid<br />

neurovascular injury while allowing predictable<br />

meniscocapsular placement 2 .<br />

Peripheral, popliteal, hiatal, and mid-1/3 medial<br />

meniscus tears may require penetration less than<br />

the 17 mm allowed by the dark blue sheath. Use of<br />

the meniscal depth probe, in conjunction with the<br />

trimmable depth penetration limiter (white plastic<br />

sheath), allows controlled penetration (Figures 1a<br />

and 1b).<br />

If the trimmable depth penetration limiter is used<br />

with the split cannula, then the split cannula should<br />

be completely split before inserting it over the<br />

white depth penetration limiter, to allow for easier<br />

removal.<br />

Photo 2. Completed repair - horizontal<br />

Photo 3. Completed repair - vertical x 2<br />

Figure 1a. Trimmable depth penetration limiter and meniscal depth<br />

probe<br />

Figure 1b. Trimmable depth penetration limiter<br />

5


Photo 4. Holding needle like a dart<br />

Photo 5. Metal slotted cannula<br />

Figure 2. Portal placement<br />

Vertical Incision<br />

Mid-1/3 and Posterior-1/3 Tears<br />

The inferolateral/inferomedial portal<br />

should be 5 mm off the patella<br />

tendon, 1 cm above the joint line.<br />

Anterior-1/3 Tears<br />

The lateral portal should be in front<br />

of the illiotibial band, 1 cm above<br />

the joint line.<br />

The medial portal should be in front<br />

of the medial collateral ligament,<br />

5 mm above the joint line.<br />

The supralateral or supramedial<br />

portal can also be used to access<br />

the anterior horn.<br />

Procedure<br />

First, locate the portals using an 18 gauge spinal<br />

needle to precisely select the insertion direction/<br />

vector. For mid-1/3 and posterior-1/3 tears, make a<br />

vertical portal incision 5 mm off the patella tendon<br />

and 1 cm above the joint line. For anterior-1/3 tears,<br />

position the lateral portal in front of the illiotibial<br />

band, 1 cm above the joint line. The medial portal<br />

should be made in front of the medial collateral<br />

ligament, 5 mm above the joint line. The supralateral<br />

or supramedial portal can be used to access the<br />

anterior horn.<br />

To create the portals, use a knife to excise the tissue<br />

through to the joint and an obturator to dilate the<br />

portal. Use a meniscal depth probe to determine if<br />

an ipsilateral or contralateral portal is best.<br />

<strong>Meniscal</strong> tear site preparation is essential and<br />

advised. <strong>Meniscal</strong> rasps and/or arthroscopic<br />

shavers are used to stimulate the tear site and the<br />

peripheral vasculature.<br />

1. Insert the <strong>ULTRA</strong> <strong>FAST</strong>-FIX Delivery Needle into<br />

the appropriate arthroscopy portal, holding it like<br />

a dart (Photo 4). Insertion is facilitated through<br />

the use of either the metal slotted cannula<br />

(Photo 5) or the blue split cannula. Place the<br />

<strong>ULTRA</strong> <strong>FAST</strong>-FIX device either through the inferior<br />

(tibial) or superior (femoral) surface of the<br />

meniscus for optimal strength.<br />

Note: For the easiest knot sliding and avoidance<br />

of the neurovascular bundles, insert the needle<br />

perpendicular to the tear using a contralateral<br />

approach. Use portals placed adjacent to<br />

the patella tendon (Figure 2) to facilitate this<br />

procedure.<br />

The split sheath cannula obviates the need for a<br />

larger cannula incision and the need to pass the<br />

needle through a diaphragm. In addition, it can<br />

be partially or totally removed by retraction and<br />

peeling.<br />

6


Caution: The opening of the split cannula must<br />

be at 90° to the curved <strong>ULTRA</strong> <strong>FAST</strong>-FIX needle<br />

to prevent the needle from slipping out as it is<br />

introduced into the knee (Figure 3). If using the<br />

slotted cannula, make sure the curve of the<br />

needle faces down (Figure 3a).<br />

To minimize needle bending, grasp the cannula<br />

on the shaft and hold it like a dart or pencil when<br />

passing through the fat pad (Photo 4).<br />

Note: The pretied, self-sliding knot, included in<br />

the <strong>ULTRA</strong> <strong>FAST</strong>-FIX device, slides from the first<br />

implant (T1) to the second implant (T2). Therefore,<br />

placing T1 further away than T2 will facilitate<br />

sliding of the knot.<br />

Note: Maintaining the needle insertion tip within<br />

the arthroscopic view at all times avoids suture<br />

tangling.<br />

2. For a horizontal repair, place the first implant (T1)<br />

farthest away and advance the needle into the<br />

outer meniscal fragment until the implant pops<br />

through the meniscus.<br />

For a vertical repair, place the superior implant<br />

first and advance the needle into the outer<br />

meniscal fragment (bisecting the fragment) until<br />

the implant pops through the meniscus (Photo 6).<br />

Using the curved <strong>ULTRA</strong> <strong>FAST</strong>-FIX device may<br />

facilitate initial penetration.<br />

Using the slotted cannula minimizes needle<br />

skiving when accessing more anterior tears.<br />

Leave the cannula in to help steer the needle tip.<br />

3. Oscillate the needle approximately 5° and pull<br />

the needle out of the meniscus, releasing<br />

T1 behind the meniscus (Figure 4).<br />

To reduce the amount of suture in the field<br />

of view, slowly pull back on the needle after<br />

deploying implant 1. Use a forefinger for control<br />

upon withdrawal. Piercing the meniscus by<br />

2–3 mm prior to advancing T2 can also help with<br />

suture management.<br />

Figure 3. Blue split cannula positioned 90° to the curve of the<br />

delivery needle<br />

Figure 3a. Needle curve facing down<br />

Photo 6. Implant 1 placed superior to tear<br />

Figure 4. Placement of implant 1<br />

7


4. Using the tip (rather than the volar pad) of the<br />

thumb, slide the gold trigger forward to advance<br />

the second implant into the ready position<br />

(Photo 7 and Figure 5).<br />

Note: It is normal to encounter resistance prior<br />

to achieving the ready position. A snap or click<br />

is heard when the trigger is fully advanced,<br />

ensuring that the implant is fully seated at the<br />

end of the needle (Figures 6 and 7).<br />

Photo 7. Implant 2 fully advanced to the ready position<br />

Figure 5. Implant 2 fully advanced to the ready position<br />

Figure 6. Proper positioning of implant 2 Figure 7. Improper positioning of implant 2<br />

8


5. Insert the delivery needle to release implant 2.<br />

≠ For a horizontal repair, insert the needle<br />

between the entry point and the first implant,<br />

approximately 4–5 mm inferior from implant 1<br />

(Figure 8, Photo 8).<br />

≠ For a vertical repair, insert the needle<br />

approximately 4–5 mm inferior from implant 1<br />

(Figure 8, Photo 9).<br />

Figure 8. Implant 2 ready for release<br />

Photo 8. Horizontal mattress suture<br />

Photo 9. Vertical mattress suture<br />

9


Figure 9. Prior to tightening suture construct<br />

6. Remove the delivery needle from the knee,<br />

leaving the free end of the suture. Pull the free<br />

end of the suture to advance the sliding knot<br />

and reduce the meniscal tear (Figure 9, Photos<br />

10 and 11). It is normal to encounter considerable<br />

resistance as the knot is snugged down. It is<br />

important to pull the free end of the suture in a<br />

line directly perpendicular to the tear site.<br />

Avoid suture breakage by wrapping the suture<br />

around several fingers and using the tibia as<br />

a fulcrum to provide a tactile feel. Apply slow,<br />

increasing tension. In most cases, this steady<br />

pulling of the suture will cinch the knot down. As<br />

the knot is tightened, it may strangle the free leg<br />

of suture, creating a loop of suture. If controlled<br />

tightening does not eliminate the loop, place a<br />

probe under the tight leg of suture and use it as<br />

a pulley.<br />

7. To further snug down the suture construct,<br />

thread the free end of the suture through the<br />

<strong>ULTRA</strong> <strong>FAST</strong>-FIX Knot Pusher/Suture Cutter. Both<br />

curved and straight knot pushers/suture cutters<br />

are available. This threading can be facilitated<br />

with the use of the suture funnel.<br />

Photo 10. Hand-tightened suture construct - vertical mattress<br />

Photo 11. Hand-tightened suture construct - horizontal mattress<br />

10


8. While holding the suture taut, gently slide the<br />

knot pusher/suture cutter to the meniscus to<br />

achieve the desired tension (Figure 10). The knot<br />

pusher should engage the suture in a direct line<br />

and perpendicular to the repair. A manual suture<br />

“pull”/“push” maneuver is suggested.<br />

9. Rest the tip against the knot to allow for a<br />

2–3 mm suture tail. Cut the suture by sliding<br />

the gold trigger forward (Photos 12 and 13,<br />

Figure 11). Alternatively, trim the suture with<br />

arthroscopic scissors.<br />

To reduce puckering that may result from<br />

the femoral surface repair, the implants can<br />

subsequently be placed on the tibial side of the<br />

meniscus to help pull down the meniscal flap.<br />

The reverse curve <strong>ULTRA</strong> <strong>FAST</strong>-FIX device is<br />

recommended for tibial side tears.<br />

Postoperative Care<br />

Reestablish full extension and quadriceps activation<br />

early, along with joint kinematics and proprioception<br />

involving the entire kinetic chain progression to full<br />

weight bearing; limit flexion to 90° for three weeks<br />

and to torsion for six weeks. Running is indicated at<br />

8–12 weeks. Cutting activities are indicated at 10–12<br />

weeks. Return to full activity is indicated at 3–6<br />

months. Individualization is based on the stability of<br />

the tear, repair construct security, and associated<br />

pathology.<br />

Figure 10. Suture construct tensioning<br />

Figure 11. Suture cutting<br />

Photo 12. Suture cutting - horizontal mattress<br />

Photo 13. Suture cutting - vertical mattress<br />

11


Additional Instruction<br />

Prior to performing this technique, consult the<br />

Instruction for Use documentation provided with<br />

individual components – including indications,<br />

contraindications, warnings, cautions, and<br />

instructions.<br />

References<br />

1. Caborn, Borden, Nyland, Pienkowski:<br />

Biomechanical Comparison of the <strong>FAST</strong>-FIX<br />

<strong>Meniscal</strong> <strong>Repair</strong> Suture <strong>System</strong> with Vertical<br />

Mattress Sutures and Meniscus Arrows.<br />

The American Journal of Sports Medicine,<br />

Vol 31, No. 3, 2003.<br />

2. Coen, Caborn, Urban, et al: Arthroscopy 1998.<br />

Courtesy of <strong>Smith</strong> & <strong>Nephew</strong>, Inc.,<br />

Endoscopy Division<br />

Caution: U.S. Federal law restricts this device to sale<br />

by or on the order of a physician.<br />

Trademarks of <strong>Smith</strong> & <strong>Nephew</strong>, registered U.S. Patent & Trademark<br />

Office.<br />

Pearls<br />

≠ Prepare site and assess geometry of reduction.<br />

≠ Reduce tear center-to-center to avoid “dog ears”/<br />

gapping/ruffles.<br />

≠ Approach tear from contralateral portal/view from<br />

ipsilateral portal.<br />

≠ Use curve of needle to increase safety zone of<br />

vector and improve insertion positioning.<br />

≠ Hold delivery needle like a dart to stabilize.<br />

≠ Insert curved delivery needle within split cannula<br />

with convexity up.<br />

≠ Ease insertion using metal slotted cannula.<br />

≠ Vertical mattress suture: T1 goes posterior and<br />

superior; T2 goes anterior and inferior.<br />

≠ Insert T2 (implant 2) 4 mm to 5 mm from T1<br />

(implant 1).<br />

≠ Advance gold slide trigger and implant 2<br />

completely to tip until a click is heard (requires<br />

force). Use the tip of the thumb on slide trigger<br />

rather than volar pad of thumb.<br />

≠ If implant 1 does not deploy, it is most likely NOT<br />

inserted through the entire meniscal tissue:<br />

advance deeper.<br />

≠ If implant 2 does not deploy, it is most likely NOT<br />

advanced to the deployment position at the tip of<br />

the delivery needle.<br />

≠ Thread suture onto knot pusher/suture cutter<br />

with suture funnel.<br />

≠ If the knot does not cinch smoothly, it usually<br />

requires a more forceful steady pull which is<br />

facilitated by wrapping the suture around several<br />

fingers like a pulley and applying traction.<br />

≠ Cinch knot to obtain compression of the suture<br />

across the tear but avoid over-cinching or<br />

puckering the tissue.<br />

≠ Alternate divergent femoral side and tibial<br />

(tensile) side suture placement.<br />

≠ Consider reverse curved devices for tibial side<br />

fixation.<br />

Endoscopy<br />

<strong>Smith</strong> & <strong>Nephew</strong>, Inc.<br />

Andover, MA 01810<br />

USA<br />

www.smith-nephew.com<br />

+1 978 749 1000<br />

+1 978 749 1108 Fax<br />

+1 800 343 5717 U.S. Customer Service<br />

©2002, 2008 <strong>Smith</strong> & <strong>Nephew</strong>, Inc.<br />

All rights reserved.<br />

02/2008 1061031 Rev. C

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!